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and in the sputum microbiota are associated with increased decline in lung function in individuals with cystic fibrosis.
No full textAlthough anaerobic bacteria exist in abundance in cystic fibrosis (CF) airways, their role in disease progression is poorly understood. We hypothesized that the presence and relative abundance of the most prevalent, live, anaerobic bacteria in sputum of adults with CF were associated with adverse clinical outcomes. This is the first study to prospectively investigate viable anaerobic bacteria present in the sputum microbiota and their relationship with long-term outcomes in adults with CF. We performed 16S rRNA analysis using a viability quantitative PCR technique on sputum samples obtained from a prospective cohort of 70 adults with CF and collected clinical data over an 8 year follow-up period. We examined the associations of the ten most abundant obligate anaerobic bacteria present in the sputum with annual rate of FEV change. The presence of and were associated with a greater annual rate of FEV change; -52.3 ml yr (95 % CI-87.7;-16.9), -67.9 ml yr (95 % CI-115.6;-20.1), respectively. Similarly, the relative abundance of these live organisms were associated with a greater annual rate of FEV decline of -3.7 ml yr (95 % CI: -6.1 to -1.3, =0.003) and -5.3 ml yr (95 % CI: -8.7 to -1.9, =0.002) for each log increment of abundance, respectively. The presence and relative abundance of certain anaerobes in the sputum of adults with CF are associated with a greater rate of long-term lung function decline. The pathogenicity of anaerobic bacteria in the CF airways should be confirmed with further longitudinal prospective studies with a larger cohort of participants
Evaluation of NEWS2 response thresholds in a retrospective observational study from a UK acute hospital.
No full textOBJECTIVE
Use of National Early Warning Score 2 (NEWS2) has been mandated in adults admitted to acute hospitals in England. Urgent clinical review is recommended at NEWS2 ≥5. This policy is recognised as requiring ongoing evaluation. We assessed NEWS2 acquisition, alerting at key thresholds and patient outcomes, to understand how response recommendations would affect clinical resource allocation.
SETTING
Adult acute hospital in England.
DESIGN
Retrospective observational cohort study.
PARTICIPANTS
100 362 consecutive admissions between November 2018 and July 2019.
OUTCOME
Death or admission to intensive care unit within 24 hours of a score.
METHODS
NEWS2 were assembled as single scores from consecutive 24-hour time frames, (the first NEWS2 termed 'Index-NEWS2'), or as all scores from the admission (termed All-NEWS2). Scores were excluded when a patient was in intensive care, in the presence of a decision not to attempt cardiopulmonary resuscitation, or on day 1 of elective admission.
RESULTS
A mean of 4.5 NEWS2 were acquired per patient per day. The outcome rate following an Index-NEWS2 was 0.22/100 patient-days. The sensitivity of outcome prediction at Index-NEWS2 ≥5=0.46, and number needed to evaluate (NNE)=52. At this threshold, a mean of 37.6 alerts/100 patient-days would be generated, occurring in 12.3% of patients on any single day. Threshold changes to increase sensitivity by 0.1, would result in a twofold increase in alert rate and 1.5-fold increase in NNE. Overall, NEWS2 classification performance was significantly worse on Index-scores than All-scores (c-statistic=0.78 vs 0.85; p<0.001).
CONCLUSIONS
The combination of low event-rate, high alert-rate and low sensitivity, in patients for cardiopulmonary resuscitation, means that at current NEWS2 thresholds, resource demand would be sufficient to meaningfully compete with other pathways to clinical evaluation. In analyses that epitomise in-patient screening, NEWS2 performance suggests a need for re-evaluation of current response recommendations in this population
Resuscitation highlights in 2021.
No full textBACKGROUND
This review is the latest in a series of regular annual reviews undertaken by the editors and aims to highlight some of the key papers published in Resuscitation during 2021.
METHODS
Hand-searching by the editors of all papers published in Resuscitation during 2021. Papers were selected based on then general interest and novelty and were categorised into themes.
RESULTS
98 papers were selected for brief mention.
CONCLUSIONS
Resuscitation science continues to evolve and incorporates all links in the chain of survival
COVID-19 vaccines elicit robust cellular immunity and clinical protection in chronic lymphocytic leukemia.
No full text
Clinical outcomes following neurolysis and porcine collagen extracellular matrix wrapping of scarred nerves in revision carpal tunnel decompression.
No full textScar tether after primary nerve decompression can impair physiological nerve glide and vascularity of the nerve. Revision decompression in the setting of neurostenalgia should address the scarred mesoneurium in order to prevent further entrapment and tether. This study reports on the clinical outcomes of 12 patients with neurostenalgia following carpal tunnel decompression (CTD), treated with revision CTD and a porcine submucosa extracellular matrix nerve wrap (PECM) (Axoguard® nerve protector, Axogen Inc., Alachua, FL). Eleven patients had one primary decompression procedure prior to revision surgery; one patient previously had two operations for CTD. There was a significant reduction in visual analogue pain scores (VAS) and improvement in patients' satisfaction rating and symptom resolution. Patient-reported outcome measures were recorded using the Impact of Hand Nerve Disorders (I-HaND) Scale (Version 2), which demonstrated a significant reduction in hand disability. There were no complications attributable to the procedure and no re-revision procedures necessary at the latest follow-up
Burnout in diabetes and endocrinology specialist registrars across England, Scotland and Wales in the pre-COVID era.
No full textBACKGROUND
Presence of either emotional exhaustion, depersonalization or lack of personal accomplishment define Burnout Syndrome which may lead to decreased workforce productivity, increased absenteeism, depression and medical errors as well as decreased patient satisfaction.
OBJECTIVE
The aim of this study was to assess the frequency of burnout syndrome among Diabetes Specialist Registrars across England, Scotland and Wales and to identify any self-reported factors which may be contributory to burnout.
METHODS
Over 430 Diabetes Specialist Registrars were invited to anonymously participate in an electronic survey which used Maslach Burnout Inventory and selfreporting questionnaire to identify burnout and contributory factors.
RESULTS
In this pre-pandemic times study, Burnout was identified in 61 (57.5%; n = 106) respondents using Maslach burnout cut-off scores. 45.2% (48/106) participants had scored high in Emotional Exhaustion, while lack of personal accomplishment and depersonalization was seen in 24.5% (26/106) and 21.6% (23/106) of the respondents respectively. The commonest self-reported stressors by participants were "General Internal Medicine workload" 60.4% (64/106) followed by "Lack of specialty training" 36.8% (39/106) and "Lack of audit/research/Continuing Professional Development time" 10.8% (11/106) CONCLUSION: Burnout syndrome is frequent among the participating Diabetes Specialist Registrars and urgent steps may be required address this problem nationally to ensure that these physicians remain physically and mentally healthy, especially after the pandemic
Guaiac-based faecal occult blood tests versus faecal immunochemical tests for colorectal cancer screening in average-risk individuals.
No full textBACKGROUND
Worldwide, many countries have adopted colorectal cancer (CRC) screening programmes, often based on faecal occult blood tests (FOBTs). CRC screening aims to detect advanced neoplasia (AN), which is defined as CRC or advanced adenomas. FOBTs fall into two categories based on detection technique and the detected blood component: qualitative guaiac-based FOBTs (gFOBTs) and faecal immunochemical tests (FITs), which can be qualitative and quantitative. Screening with gFOBTs reduces CRC-related mortality.
OBJECTIVES
To compare the diagnostic test accuracy of gFOBT and FIT screening for detecting advanced colorectal neoplasia in average-risk individuals.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, BIOSIS Citation Index, Science Citation Index Expanded, and Google Scholar. We searched the reference lists and PubMed-related articles of included studies to identify additional studies.
SELECTION CRITERIA
We included prospective and retrospective studies that provided the number of true positives, false positives, false negatives, and true negatives for gFOBTs, FITs, or both, with colonoscopy as reference standard. We excluded case-control studies. We included studies in which all participants underwent both index test and reference standard ("reference standard: all"), and studies in which only participants with a positive index test underwent the reference standard while participants with a negative test were followed for at least one year for development of interval carcinomas ("reference standard: positive"). The target population consisted of asymptomatic, average-risk individuals undergoing CRC screening. The target conditions were CRC and advanced neoplasia (advanced adenomas and CRC combined).
DATA COLLECTION AND ANALYSIS
Two review authors independently screened and selected studies for inclusion. In case of disagreement, a third review author made the final decision. We used the Rutter and Gatsonis hierarchical summary receiver operating characteristic model to explore differences between tests and identify potential sources of heterogeneity, and the bivariate hierarchical model to estimate sensitivity and specificity at common thresholds: 10 µg haemoglobin (Hb)/g faeces and 20 µg Hb/g faeces. We performed indirect comparisons of the accuracy of the two tests and direct comparisons when both index tests were evaluated in the same population.
MAIN RESULTS
We ran the initial search on 25 June 2019, which yielded 63 studies for inclusion. We ran a top-up search on 14 September 2021, which yielded one potentially eligible study, currently awaiting classification. We included a total of 33 "reference standard: all" published articles involving 104,640 participants. Six studies evaluated only gFOBTs, 23 studies evaluated only FITs, and four studies included both gFOBTs and FITs. The cut-off for positivity of FITs varied between 2.4 μg and 50 µg Hb/g faeces. For each Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 domain, we assessed risk of bias as high in less than 20% of studies. The summary curve showed that FITs had a higher discriminative ability than gFOBTs for AN (P < 0.001) and CRC (P = 0.004). For the detection of AN, the summary sensitivity of gFOBTs was 15% (95% confidence interval (CI) 12% to 20%), which was significantly lower than FITs at both 10 μg and 20 μg Hb/g cut-offs with summary sensitivities of 33% (95% CI 27% to 40%; P < 0.001) and 26% (95% CI 21% to 31%, P = 0.002), respectively. Results were simulated in a hypothetical cohort of 10,000 screening participants with 1% CRC prevalence and 10% AN prevalence. Out of 1000 participants with AN, gFOBTs missed 850, while FITs missed 670 (10 μg Hb/g cut-off) and 740 (20 μg Hb/g cut-off). No significant differences in summary specificity for AN detection were found between gFOBTs (94%; 95% CI 92% to 96%), and FITs at 10 μg Hb/g cut-off (93%; 95% CI 90% to 95%) and at 20 μg Hb/g cut-off (97%; 95% CI 95% to 98%). So, among 9000 participants without AN, 540 were offered (unnecessary) colonoscopy with gFOBTs compared to 630 (10 μg Hb/g) and 270 (20 μg Hb/g) with FITs. Similarly, for the detection of CRC, the summary sensitivity of gFOBTs, 39% (95% CI 25% to 55%), was significantly lower than FITs at 10 μg and 20 μg Hb/g cut-offs: 76% (95% CI 57% to 88%: P = 0.001) and 65% (95% CI 46% to 80%; P = 0.035), respectively. So, out of 100 participants with CRC, gFOBTs missed 61, and FITs missed 24 (10 μg Hb/g) and 35 (20 μg Hb/g). No significant differences in summary specificity for CRC were found between gFOBTs (94%; 95% CI 91% to 96%), and FITs at the 10 μg Hb/g cut-off (94%; 95% CI 87% to 97%) and 20 μg Hb/g cut-off (96%; 95% CI 91% to 98%). So, out of 9900 participants without CRC, 594 were offered (unnecessary) colonoscopy with gFOBTs versus 594 (10 μg Hb/g) and 396 (20 μg Hb/g) with FITs. In five studies that compared FITs and gFOBTs in the same population, FITs showed a higher discriminative ability for AN than gFOBTs (P = 0.003). We included a total of 30 "reference standard: positive" studies involving 3,664,934 participants. Of these, eight were gFOBT-only studies, 18 were FIT-only studies, and four studies combined both gFOBTs and FITs. The cut-off for positivity of FITs varied between 5 µg to 250 µg Hb/g faeces. For each QUADAS-2 domain, we assessed risk of bias as high in less than 20% of studies. The summary curve showed that FITs had a higher discriminative ability for detecting CRC than gFOBTs (P < 0.001). The summary sensitivity for CRC of gFOBTs, 59% (95% CI 55% to 64%), was significantly lower than FITs at the 10 μg Hb/g cut-off, 89% (95% CI 80% to 95%; P < 0.001) and the 20 μg Hb/g cut-off, 89% (95% CI 85% to 92%; P < 0.001). So, in the hypothetical cohort with 100 participants with CRC, gFOBTs missed 41, while FITs missed 11 (10 μg Hb/g) and 11 (20 μg Hb/g). The summary specificity of gFOBTs was 98% (95% CI 98% to 99%), which was higher than FITs at both 10 μg and 20 μg Hb/g cut-offs: 94% (95% CI 92% to 95%; P < 0.001) and 95% (95% CI 94% to 96%; P < 0.001), respectively. So, out of 9900 participants without CRC, 198 were offered (unnecessary) colonoscopy with gFOBTs compared to 594 (10 μg Hb/g) and 495 (20 μg Hb/g) with FITs. At a specificity of 90% and 95%, FITs had a higher sensitivity than gFOBTs.
AUTHORS' CONCLUSIONS
FITs are superior to gFOBTs in detecting AN and CRC in average-risk individuals. Specificity of both tests was similar in "reference standard: all" studies, whereas specificity was significantly higher for gFOBTs than FITs in "reference standard: positive" studies. However, at pre-specified specificities, the sensitivity of FITs was significantly higher than gFOBTs
Reporting guideline for the early-stage clinical evaluation of decision support systems driven by artificial intelligence: DECIDE-AI.
No full textA growing number of artificial intelligence (AI)-based clinical decision support systems are showing promising performance in preclinical, in silico evaluation, but few have yet demonstrated real benefit to patient care. Early-stage clinical evaluation is important to assess an AI system's actual clinical performance at small scale, ensure its safety, evaluate the human factors surrounding its use and pave the way to further large-scale trials. However, the reporting of these early studies remains inadequate. The present statement provides a multi-stakeholder, consensus-based reporting guideline for the Developmental and Exploratory Clinical Investigations of DEcision support systems driven by Artificial Intelligence (DECIDE-AI). We conducted a two-round, modified Delphi process to collect and analyze expert opinion on the reporting of early clinical evaluation of AI systems. Experts were recruited from 20 pre-defined stakeholder categories. The final composition and wording of the guideline was determined at a virtual consensus meeting. The checklist and the Explanation & Elaboration (E&E) sections were refined based on feedback from a qualitative evaluation process. In total, 123 experts participated in the first round of Delphi, 138 in the second round, 16 in the consensus meeting and 16 in the qualitative evaluation. The DECIDE-AI reporting guideline comprises 17 AI-specific reporting items (made of 28 subitems) and ten generic reporting items, with an E&E paragraph provided for each. Through consultation and consensus with a range of stakeholders, we developed a guideline comprising key items that should be reported in early-stage clinical studies of AI-based decision support systems in healthcare. By providing an actionable checklist of minimal reporting items, the DECIDE-AI guideline will facilitate the appraisal of these studies and replicability of their findings